Real-World Patient Experiences Using Continuous Subcutaneous Apomorphine Infusion (ONAPGOTM) in the United States:
Recruiting · NCT07219927 · Observational (researchers observe without assigning treatment) · Lead sponsor: Supernus Pharmaceuticals, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
Observational study
What this trial is about
Real-World Participants Experiences Using Continuous Subcutaneous Apomorphine Infusion (ONAPGOTM) in the United States: A Prospective, Phase 4, Multicenter, Observational Study in Parkinson's Disease
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Participant has received a prescription for ONAPGO™ according to the standard of care.
- Participant has opted into receiving support services from the Clinical Nurse Navigator (CNN), a registered nurse specially trained to work with persons with Parkinson's disease, as noted on the Prescription Enrollment Form.
- The HCP/Investigator determines the participant is an appropriate study participant.
- Participant is able and willing to provide informed consent (or informed assent form \[IAF\], as applicable) and signs the consent form on the Enrollment Day.
Exclusion criteria
- Did not receive a prescription for ONAPGO™.
- Prescribed ONAPGO™, but the HCP/Investigator determines the participant should not participate in this observational study.
- Concomitant use of ONAPGO™ with 5-HT3 antagonists, including antiemetics (e.g., ondansetron, granisetron, dolasetron, palonosetron) or alosetron.
- Known hypersensitivity to apomorphine or to excipients of ONAPGO™, including sulfite (e.g., sodium metabisulfite).
Where it is running
5 locations listed across 3 US states.
- Parkinson's Disease and Movement Disorders Center - Orange County (South) - Aliso Viejo, California, United States
- Parkinson's Disease and Movement Disorders Center - Orange County (North) - Irvine, California, United States
- Parkinson's Research Centers of America - Palo Alto - Palo Alto, California, United States
- Parkinson's Disease & Movement Disorders Center of Boca Raton - Boca Raton, Florida, United States
- Parkinson's Disease and Movement Disorders Center - Long Island - Commack, New York, United States